Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | August 28, 2017 |
| End Date: | August 20, 2019 |
| Contact: | Konstantinos Spaniolas, MD |
| Email: | konstantinos.spaniolas@stonybrookmedicine.edu |
| Phone: | 631-444-7298 |
Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and
vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses
on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and
aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The
investigators hypothesize that the intervention group will experience a reduction of
nausea-related prolonged hospital stay and significantly improve patient-reported quality of
recovery from surgery and quality of life.
vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses
on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and
aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The
investigators hypothesize that the intervention group will experience a reduction of
nausea-related prolonged hospital stay and significantly improve patient-reported quality of
recovery from surgery and quality of life.
To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two
groups: control vs Nausea specific-intervention group. All subjects will be assessed with a
nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient
satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24
hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life
and quality of recovery, will allow the investigators to identify an effect on incidence and
severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate
for an impact in patient-reported measures of quality of life.
The total sample size is 82. This study will provide valuable insight on the epidemiology of
post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy,
which is currently poorly characterized. By allowing the investigators to assess the overall
incidence of nausea and vomiting at different time points, this study will afford the
opportunity to identify a time period of high incidence and further adjust our prevention
efforts accordingly in future studies.
groups: control vs Nausea specific-intervention group. All subjects will be assessed with a
nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient
satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24
hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life
and quality of recovery, will allow the investigators to identify an effect on incidence and
severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate
for an impact in patient-reported measures of quality of life.
The total sample size is 82. This study will provide valuable insight on the epidemiology of
post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy,
which is currently poorly characterized. By allowing the investigators to assess the overall
incidence of nausea and vomiting at different time points, this study will afford the
opportunity to identify a time period of high incidence and further adjust our prevention
efforts accordingly in future studies.
Inclusion Criteria:
- Adult patients (18 years and older) undergoing LSG
Exclusion Criteria:
- Allergy to medications delineated in the protocol (muscle blockade, anesthetics,
reversal agents)
- Inability to provide informed consent
- History of chronic nausea and emesis requiring medication
- Poorly controlled diabetes (HgA1c>9 mg/dl),
- History of previous bariatric or gastro-esophageal surgery
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